FDA Product Code DTN: Reservoir, Blood, Cardiopulmonary Bypass
Leading manufacturers include Sorin Group Italia S.R.L..
2
Total
2
Cleared
207d
Avg days
2023
Since
List of Reservoir, Blood, Cardiopulmonary Bypass devices cleared through 510(k)
2 devices
Cleared
Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
Sorin Group Italia S.R.L.
Cardiovascular
194d
Cleared
Jun 10, 2023
BMR 1900 PHISIO
Sorin Group Italia S.R.L.
Cardiovascular
219d
How to use this database
This page lists all FDA 510(k) submissions for Reservoir, Blood, Cardiopulmonary Bypass devices (product code DTN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →